Comparison of Upper and Lower Body Air Warming in Patient... | NCT02993666

Studies
Comparison of Upper and Lower Body Air Warming in Patients Undergoing Thoracic Surgery

NCT02993666

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Jun 12, 2017Actual

Enrollment

135Actual

Phase

Not Applicable

Conditions

Core Body Temperature

Interventions

Bair Hugger

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2016Actual

Primary Completion Date

Jun 2017Actual

Completion Date

Jun 2017Actual

First Submitted Date

Dec 1, 2016

First Submission Date that Met QC Criteria

Dec 13, 2016

First Posted Date

Dec 15, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2017

Last Update Posted Date

Jun 12, 2017Actual

Description Module

Brief Summary

This study is conducted to evaluate the effectiveness of forced air warming using upper and lower body blankets by measuring core body temperature in patients undergoing video-assisted thoracic surgery in the lateral decubitus position over 2 hours of general anesthesia.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

135Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
upper body	Experimental	warming with upper body blankets	Device: Bair Hugger
lower body	Experimental	warming with lower body blankets	Device: Bair Hugger

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bair Hugger	Device	forced air warming with Bair Hugger air warmer	lower body upper body

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
intraoperative incidence of hypothermia		through surgery completion, up to 4 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients undergoing video-assisted thoracic surgery over 2 hours
ASA I, II and III
age over 18 years

Exclusion Criteria:

refuse to enroll
patients with fever or hypothermia before surgery
patients who required changes of position during surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
JH Seo	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul			South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29452812	Derived	Min SH, Yoon S, Yoon SH, Bahk JH, Seo JH. Randomised trial comparing forced-air warming to the upper or lower body to prevent hypothermia during thoracoscopic surgery in the lateral decubitus position. Br J Anaesth. 2018 Mar;120(3):555-562. doi: 10.1016/j.bja.2017.11.091. Epub 2017 Dec 5.